500 lung cancer patients enrolled in quest for smarter radiotherapy
NCT ID NCT07565532
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is gathering detailed information from 500 people with small cell lung cancer to learn how to tailor treatments like radiation and immunotherapy to each patient. The goal is to find the best timing and doses of radiotherapy to work with immunotherapy, improving outcomes and reducing side effects. Participants will be followed over time to track cancer progression and survival.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients diagnosed with small-cell lung cancer
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Inclusion Criteria for Limited-Stage Small Cell Lung Cancer (LS-SCLC): 1\. Voluntary signed informed consent according to clinical routine practice. 2. Histologically and radiologically confirmed, previously untreated limited-stage SCLC (according to the Veterans Administration Lung Study Group staging system). 3\. Age ≥ 18 years. 4. Life expectancy ≥ 8 weeks. 5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. 6. At least one documented efficacy assessment. 7. At least one measurable lesion as confirmed by the investigator according to RECIST (iRECIST 2017) criteria. 8\. Adequate organ and bone marrow function, with laboratory tests performed within 7 days prior to the first dose meeting the following criteria (without receiving any blood components, hematopoietic growth factors, albumin, or other corrective therapies considered by the investigator within 14 days prior to laboratory assessments): 1. Hematology: Hemoglobin (Hb) ≥ 90 g/L, absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, platelet count (PLT) ≥ 90 × 10⁹/L. 2. Biochemistry: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); serum total bilirubin (TBIL) ≤ 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN in patients without liver metastases, or ≤ 5.0 × ULN in patients with liver metastases; serum albumin (ALB) ≥ 25 g/L. 3. Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN; prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for patients receiving prophylactic anticoagulation, the INR and APTT values should be judged by the treating physician or investigator to be within a safe and effective therapeutic range). 9\. Pulmonary function test showing FEV₁ \> 0.75 L. 10. No evidence of severe interstitial lung disease confirmed by CT or PET/CT prior to treatment. 11\. No prior or concurrent primary malignancy at other sites. 12. No requirement for PD-L1 expression level. Inclusion Criteria for Extensive-Stage Small Cell Lung Cancer (ES-SCLC): 1\. Voluntary signed informed consent according to clinical routine practice. 2. Histologically confirmed SCLC with complete staging workup showing extensive-stage disease (according to the Veterans Administration Lung Study Group staging system). 3\. Age ≥ 18 years. 4. Life expectancy ≥ 8 weeks. 5. At least one documented efficacy assessment. 6. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2. 7. Adequate organ and bone marrow function, with laboratory tests performed within 7 days prior to the first dose meeting the following criteria (without receiving any blood components, hematopoietic growth factors, albumin, or other corrective therapies considered by the investigator within 14 days prior to laboratory assessments): 1. Hematology: Hemoglobin (Hb) ≥ 90 g/L, absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, platelet count (PLT) ≥ 90 × 10⁹/L. 2. Biochemistry: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); serum total bilirubin (TBIL) ≤ 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN in patients without liver metastases, or ≤ 5.0 × ULN in patients with liver metastases; serum albumin (ALB) ≥ 25 g/L. 3. Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN; prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for patients receiving prophylactic anticoagulation, the INR and APTT values should be judged by the treating physician or investigator to be within a safe and effective therapeutic range). 8\. No severe concurrent medical illness. 9. Forced expiratory volume in one second (FEV₁) \> 0.75 L. 10. For patients with prior radiotherapy to the primary lesion, the current radiotherapy target is limited to metastatic lesions. 11\. No prior or concurrent primary malignancy at other sites. 12. No requirement for PD-L1 expression level. 13. For patients with limited-stage SCLC who previously received curative-intent treatment, upon recurrence or metastasis, if complete staging workup is available and this is their first use of immunotherapy, they may still be considered for inclusion in the extensive-stage cohort. Exclusion Criteria: Exclusion Criteria for Limited-Stage Small Cell Lung Cancer (LS-SCLC): 1. Histologically confirmed non-small cell lung cancer (NSCLC). 2. No efficacy assessment record, or missing efficacy assessment data. 3. Presence of other primary malignancies; history of allogeneic organ transplantation. 4. Major surgery (excluding diagnostic biopsy) within 4 weeks prior to the first dose. 5. History of substance abuse (e.g., drug addiction), long-term alcoholism, or AIDS or HIV carrier. 6. Active autoimmune disease, or history of autoimmune disease with potential for relapse. 7. Current systemic corticosteroid therapy (e.g., equivalent to \>10 mg prednisone daily) or use of any other form of immunosuppressive therapy within 14 days prior to the first dose. 8. Prior treatment with any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints), including but not limited to PD-1, PD-L1, CTLA-4, TIM-3, and LAG-3. 9. Interstitial lung disease (ILD) or history of ILD requiring corticosteroid therapy. 10. History of idiopathic pulmonary fibrosis (IPF), drug-induced pneumonitis, organizing pneumonia (e.g., bronchiolitis obliterans), idiopathic pneumonia, or evidence of active pneumonitis on screening chest CT. 11. Receipt of live vaccine within 28 days prior to the first dose of study drug. 12. Any other disease or condition that contraindicates chemoradiotherapy, including but not limited to active infection, within 6 months post-myocardial infarction, symptomatic heart disease (including unstable angina, congestive heart failure, or uncontrolled arrhythmias), and immunosuppressive therapy. 13. Unresolved toxicity of Grade 2 or higher (according to CTCAE version 5.0). 14. Pregnant or breastfeeding women; men or women of childbearing potential who are unwilling to use adequate contraceptive measures. 15. Evidence of inherited bleeding diathesis or coagulation disorders. 16. Prior history of malignancy (excluding skin cancer, or in situ breast cancer, oral cancer, or cervical cancer with life expectancy \>3 years). Exclusion Criteria for Extensive-Stage Small Cell Lung Cancer (ES-SCLC): 1. Pulmonary carcinoid or non-small cell lung cancer, unless transformed SCLC is ruled out. 2. No efficacy assessment record, or missing efficacy assessment data. 3. History of severe anaphylactic/allergic reaction to humanized antibodies or fusion proteins. 4. Acute exacerbation of chronic obstructive pulmonary disease (COPD) or other pulmonary diseases requiring hospitalization. 5. Active or prior autoimmune disease (within the past 2 years) or history of primary immunodeficiency. 6. Progression after immunotherapy; prior or concurrent diagnosis of any other malignancy, excluding non-melanoma skin cancer or carcinoma in situ of the cervix. 7. Any other disease or condition that contraindicates chemoradiotherapy, including but not limited to active infection, within 6 months post-myocardial infarction, symptomatic heart disease (including unstable angina, congestive heart failure, or uncontrolled arrhythmias), or immunosuppressive therapy. 8. Unresolved toxicity of Grade 2 or higher (according to CTCAE version 5.0). 9. Current or prior history of autoimmune disease or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, and rheumatoid arthritis. 10. History of idiopathic pulmonary fibrosis (IPF), organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonia; or evidence of active pneumonitis on chest CT scan. Patients with a history of radiation pneumonitis (fibrosis) within the radiation field may be enrolled. 11. Pregnant or breastfeeding women; men or women of childbearing potential who are unwilling to use adequate contraceptive measures.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai Chest Hospital
RECRUITINGShanghai, Shanghai Municipality, 200030, China
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